JAK Inhibitor Safety — SCE Rheumatology MCQ

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ModerateRheumatology PharmacologyJAK Inhibitor SafetySCE Rheumatology

A 58-year-old woman with rheumatoid arthritis is receiving baricitinib 4 mg once daily. She has no recognised cardiovascular or malignancy risk factors. The MHRA nevertheless recommends periodic skin examinations for all patients receiving a JAK inhibitor. Which cutaneous malignancy category was specifically reported at increased incidence with tofacitinib compared with TNF inhibitor treatment and prompted this recommendation?

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Correct answer: A — Non-melanoma skin cancer

The correct answer is non-melanoma skin cancer (NMSC). In the rheumatoid arthritis safety study of tofacitinib, NMSC occurred more frequently than with TNF inhibitor treatment. Following its class review, the MHRA recommended periodic skin examinations for all patients receiving JAK inhibitors, including baricitinib, irrespective of whether they have recognised cardiovascular or malignancy risk factors. Current UK baricitinib product information retains this recommendation and particularly emphasises patients with skin-cancer risk factors. Melanoma, primary cutaneous lymphoma, Kaposi sarcoma and cutaneous sarcoma were not the specific cutaneous safety signal underlying the universal examination recommendation. Suspicious lesions should be investigated appropriately, but routine specialist dermatology review is not mandated for every patient.

Reference: Medicines and Healthcare products Regulatory Agency. Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality. Drug Safety Update, 26 April 2023. https://www.gov.uk/drug-safety-update/janus-kinase-jak-inhibitors-new-measures-to-reduce-risks-of-major-cardiovascular-events-malignancy-venous-thromboembolism-serious-infections-and-increased-mortality